FDA cleared the Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT from Covidien, LLC on Dec 29, 2025 under K251313, a traditional 510(k). The device falls under product code JOH, Tube Tracheostomy And Tube Cuff, regulated at 21 CFR 868.5800 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Apr 28, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).
Questions & Answers
What did FDA clear under K251313?
K251313 is the FDA 510(k) for Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT, submitted by Covidien, LLC. FDA's decision date was Dec 29, 2025, under product code JOH (Tube Tracheostomy And Tube Cuff).
Who makes the Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT?
Covidien, LLC, based in Boulder, CO, is the applicant of record for K251313.
How long did the K251313 review take?
FDA received the submission on Apr 28, 2025 and issued its decision on Dec 29, 2025, 245 days later.